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Centinel Spine announced FDA premarket application (PMA) approval for 1-level indications for three additional cervical total disc replacement (TDR) devices: prodisc C Vivo, prodisc C Nova, and prodisc C SK. These join the currently available prodisc C implant, which continues to be widely used throughout the U.S.
prodisc C Vivo and prodisc C Nova products have been in use outside the U.S. since 2009, and prodisc C Vivo is reported to be the most frequently implanted TDR outside of the U.S. prodisc C Vivo has keel-less endplates including a convex, superior endplate to match more concave vertebral anatomy, while the prodisc C SK and prodisc C Nova implant designs have flat endplates with low-profile keels to better match flat vertebral anatomy. All of those products incorporate prodisc CORE technology, the basis behind the predictable clinical outcomes of every prodisc device after 30 years and over 225,000 implantations, worldwide.
Centinel Spine announced FDA premarket application approval for 1-level indications for three additional cervical total disc replacement (TDR) devices. Pictured are the prodisc C portfolio of recently approved devices. Photo courtesy of Centinel Spine.
“The FDA approval of the prodisc C Vivo, Nova, and SK devices offers the surgeon a new level of modularity and stability for cervical disc replacement,” said Jason Tinley, MD, orthopedic spine surgeon and founder of DFW Center for Spinal Disorders in Dallas-Fort Worth, Texas. “The patient can now receive an implant that best conforms to their anatomy intraoperatively, with variable endplate characteristics that best suit the surgeon’s preference of technique,” Dr. Tinley adds.
Centinel Spine’s CEO, Steve Murray, said, “anatomic cervical total disc options provide surgeons the benefit of selecting implants to optimally fit the disc to each patient. This is unique and represents a major advancement in spinal reconstruction. PMA approval for these three additional devices is a significant accomplishment and we look forward to bringing the new prodisc options to the market in Q4 2022.”
Centinel Spine also continues to enroll for a two-level prospective, randomized, multi-centered clinical study evaluating prodisc C Vivo and prodisc C SK.
